Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 14, 2019

DrugPatentWatch Database Preview

LEVITRA Drug Profile

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Which patents cover Levitra, and what generic alternatives are available?

Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-four patent family members in thirty-one countries.

The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

Drug patent expirations by year for LEVITRA
Drug Prices for LEVITRA

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Drug Sales Revenue Trends for LEVITRA

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Recent Clinical Trials for LEVITRA

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SponsorPhase
A2 Healthcare Taiwan CorporationPhase 1/Phase 2
Tritech Biopharmaceuticals Co., Ltd.Phase 1/Phase 2
Azienda USL ModenaPhase 2

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Recent Litigation for LEVITRA

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District Court Litigation
Case NameDate
Bayer Pharma AG v. Par Pharmaceutical Inc.2013-05-14
Bayer Pharma AG v. Watson Laboratories, Inc.2012-04-25
Bayer Schering Pharma AG v. Teva Pharmaceuticals USA Inc.2010-07-20

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Pharmacology for LEVITRA

US Patents and Regulatory Information for LEVITRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003 DISCN Yes No   See Pricing   See Pricing   See Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 AB RX Yes Yes   See Pricing   See Pricing   See Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003 AB RX Yes No   See Pricing   See Pricing Y   See Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 AB RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LEVITRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003   See Pricing   See Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003   See Pricing   See Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003   See Pricing   See Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for LEVITRA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 2.5 mg ➤ Subscribe   See Pricing
➤ Subscribe Tablets 5 mg ad 10 mg ➤ Subscribe   See Pricing
➤ Subscribe Tablets 20 mg ➤ Subscribe   See Pricing

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